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NCT03948178 · ClinicalTrials.gov registry record · Phase 3
Effects of Oral Levosimendan on Respiratory Function in Patients With Amyotrophic Lateral Sclerosis (ALS): Open-Label Extension
A Phase 3 study, sponsored by Orion Corporation, Orion Pharma.
- Terminated
- Registry status
- Phase 3
- Development phase
- 227
- Enrollment target
NCT03948178: Clinical Trial Phase 3 study, sponsored by Orion Corporation, Orion Pharma.
NCT03948178 is a Phase 3 study that was terminated before completion, run by Orion Corporation, Orion Pharma. The registered enrollment target is 227 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03948178, a Phase 3 study, was terminated before completion, sponsored by Orion Corporation, Orion Pharma.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 227 participants
- Enrollment target
Study Summary
This study provides an opportunity for subjects in the REFALS (3119002; NCT03505021) study to continue treatment with oral levosimendan. The study will also provide more information about long-term safety and effectiveness of oral levosimendan in patients with ALS. This is an open-label study, so that all eligible subjects that complete the double-blind REFALS study (48-weeks of treatment) will have the opportunity to receive oral levosimendan treatment. The primary objective, in addition to continuing treatment for subjects enrolled in the REFALS study, is to evaluate long-term safety of oral levosimendan in ALS patients. Another important objective is to explore long-term effectiveness of oral levosimendan in the treatment of patients with ALS. This study is open only to patients taking part in the REFALS study.
Primary Outcome
Adverse Events as subject counts and proportions (%) of subject per Adverse Event
Interventions
- DRUG Levosimendan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 227 participants |
| Start Date | 2019-06-26 |
| Est. Completion | 2020-11-18 |
| Phase | Phase 3 |
Why NCT03948178 stopped before completion
NCT03948178 is an interventional study that assigns participants to a tested intervention. The registered 227 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 1 intervention - of which Levosimendan is the first listed.
NCT03948178 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03948178 about?
NCT03948178 is a clinical study titled "Effects of Oral Levosimendan on Respiratory Function in Patients With Amyotrophic Lateral Sclerosis (ALS): Open-Label Extension". This study provides an opportunity for subjects in the REFALS (3119002; NCT03505021) study to continue treatment with oral levosimendan. The study will also provide more information about long-term safety and effectiveness of oral levosimendan in patients with ALS. This is an open-label study, so t...
What is the current status of trial NCT03948178?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 227 participants. The study started on 2019-06-26. Estimated completion is 2020-11-18.
What interventions are being tested in trial NCT03948178?
The interventions under investigation include: Levosimendan (DRUG).
Who is sponsoring clinical trial NCT03948178?
This trial is sponsored by Orion Corporation, Orion Pharma, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03948178's enrollment target sits among peer trials
227 1310th of 2000 higher than 691 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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